Apparatus for vessel access closure

ABSTRACT

Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

RELATED APPLICATION DATA

The present application claims the benefit under 35 U.S.C. §119 to U.S.provisional patent application Ser. Nos. 61/308,859 filed Feb. 26, 2010,and 61/353,561 filed Jun. 10, 2010. The foregoing applications arehereby incorporated by reference into the present application in theirentirety.

FIELD OF THE INVENTION

The present invention relates generally to closure of surgically createdvascular access ports or holes, such as arteriotomies, and morespecifically to closure technologies pertinent to relatively largesurgically-created access defects.

BACKGROUND

Minimally invasive diagnostic and interventional procedure prevalence inUS and foreign hospitals continues to increase, as does the demand forcertain procedures which involve placement of relatively large devicesinto targeted locations that are initially accessed through thevasculature. For example, percutaneous prosthetic heart valve placementand ascending aortic aneurysm stent graft procedures that are notaccomplished using one or more trans-thoracic or trans-abdominal accessports generally involve one or more femoral arteriotomies which may belarge in size relative to conventional femoral arteriotomies, due, atleast in part, to the size of devices utilized for such procedures.Subsequent to completion of the diagnostic or interventional aspects ofsuch treatments, any associated arteriotomies generally must be closed.While there are existing technologies for closing defects created inveins and arteries due to diagnostic and/or interventional tool access,such as those available from St. Jude Medical, Inc., AbbottLaboratories, Inc., and Access Closure, Inc. under the tradenamesAngio-Seal®, StarClose®, and Mynx®, respectively, none of these are wellsuited for closing relatively large defects—particularly not in thearterial environment wherein relatively high flow rate and pressure arecomplicating factors.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1E illustrate aspects of an access closure device deploymentwherein a collapsed device is passed through an introducer lumen to atargeted intravascular deployment position before it is deployed.

FIGS. 1F and 1G illustrate cross sectional views of two differentembodiments of deployed closure device configurations.

FIGS. 1H-1J illustrate orthogonal views of two different embodiments ofdeployed closure device configurations.

FIGS. 1K and 1L illustrate cross sectional views of two differentembodiments of deployed closure device configurations.

FIGS. 2A-2F illustrate aspects of an access closure device deploymentwherein a two-portion collapsed device is passed through an introducerlumen to a targeted intravascular deployment position before expansion.

FIGS. 2G-2I illustrate side views and an orthogonal view, respectively,of a suitable device frame configuration.

FIGS. 3A-3D illustrate orthogonal views of a device embodiment that maybe rolled up into a collapsed shape, and unrolled or unfurled to anexpanded shape.

FIG. 4 illustrates one embodiment of a manual operational interfaceconfiguration.

FIG. 5 illustrates various aspects of an arteriotomy closure method inaccordance with the present invention.

FIGS. 6A-6X illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be controllablyrotated relative to an elongate deployment member to prevent withdrawalof the closure device through the arteriotomy.

FIGS. 7A-7F illustrate various aspects of an arteriotomy closure devicedeployment wherein a collapsed closure device may be controllablyrotated relative to an elongate deployment member to prevent withdrawalof the closure device through the arteriotomy.

FIG. 8A illustrates aspects of deployment steps using a configurationsuch as that illustrated in FIGS. 6A-6X, wherein a foot is pre-biased toflex once released from a restraining sheath.

FIG. 8B illustrates aspects of deployment steps using a configurationsuch as that illustrated in FIGS. 6A-6X, wherein a foot is flexed afterrelease from a restraining sheath, subsequent to application of aflexing load.

FIGS. 9A-9E illustrate various aspects of arteriotomy closureconfigurations wherein a collapsed closure device may be controllablyrotated relative to an elongate deployment member to prevent withdrawalof the closure device through the arteriotomy.

FIG. 10 illustrates aspects of deployment steps using a configurationsuch as that illustrated in FIGS. 9A-9E, wherein a foot is pre-biased toflex once released from a restraining sheath.

FIG. 11 illustrates aspects of a deployment sheath configured to assistan operator with positioning of related instrumentation adjacent anarteriotomy location.

FIGS. 12A-12D illustrate aspects of a proximal deployment interfacewhich may be utilized with closure device deployment configurations suchas those depicted in FIGS. 9A-9E.

SUMMARY

One embodiment is directed to an apparatus for closing an opening in ablood vessel, comprising a closure device removably coupled to adelivery member, the closure device configured such that upon passagethrough the opening, the closure device is controllably expandable froma collapsed state to an expanded state, wherein the closure devicerestricts fluids from exiting the opening; and controllably decouplablefrom the delivery member. The closure device may be a self expandingstructure configured to expand itself from the collapsed state to theexpanded state when not restrained in the collapsed state. The closuredevice expanded state may form a generally cylindrical shape defining alumen therethrough. The closure device may comprise a frame structureand a cover member coupled to the frame structure in at least onelocation, wherein the frame structure is configured to retain a positionwithin the blood vessel in its expanded state, and wherein the covermember has a thickness and is configured to at least temporarily resistthe flow of blood across the thickness. The deployment member may have aproximal portion and a controllably movable distal portion, the distalportion being coupled to the closure device, wherein the distal portionmay be moved from a first configuration wherein the distal portion issubstantially aligned with the proximal portion, to a secondconfiguration, wherein the distal portion is rotated relative to theproximal portion in a manner selected to prevent the closure device fromexiting the opening in the blood vessel. The controllably movable distalportion may be biased to rotate to the second configuration when notconstrained to remain in the first configuration. The apparatus mayfurther comprise a rotation actuating member that may be utilized toapply a tensile load to the movable distal portion to cause the distalportion to rotate.

Another embodiment is directed to an apparatus for closing an opening ina blood vessel, the blood vessel having an inner surface that defines alumen having a longitudinal axis, comprising an expandable closuredevice controllably expandable from a collapsed state to an expandedstate, and configured such that upon passage through the opening andexpansion to the expanded state, the closure device contacts at least 90degrees of an inner surface of the vessel adjacent the opening relativeto the longitudinal axis, and restricts fluids from exiting the opening.The closure device may be a self expanding structure configured toexpand itself from the collapsed state to the expanded state when notrestrained in the collapsed state. The closure device expanded state mayform a generally cylindrical shape defining a lumen therethrough. Theclosure device may comprise a frame structure and a cover member coupledto the frame structure in at least one location, wherein the framestructure is configured to retain a position within the blood vessel inits expanded state, and wherein the cover member has a thickness and isconfigured to at least temporarily resist the flow of blood across thethickness. The deployment member may have a proximal portion and acontrollably movable distal portion, the distal portion being coupled tothe closure device, wherein the distal portion may be moved from a firstconfiguration wherein the distal portion is substantially aligned withthe proximal portion, to a second configuration, wherein the distalportion is rotated relative to the proximal portion in a manner selectedto prevent the closure device from exiting the opening in the bloodvessel. The controllably movable distal portion may be biased to rotateto the second configuration when not constrained to remain in the firstconfiguration. The apparatus may further comprise a rotation actuatingmember that may be utilized to apply a tensile load to the movabledistal portion to cause the distal portion to rotate.

Another embodiment is directed to an apparatus for closing an opening ina blood vessel, comprising a closure device that is controllablyexpandable from a collapsed state to an expanded state; wherein in thecollapsed state, the closure device is insertable through the opening inthe blood vessel, and wherein in the expanded state, the closure deviceis coupled to an inner surface of the blood vessel and configured torestrict fluids from exiting the opening. The closure device may be aself expanding structure configured to expand itself from the collapsedstate to the expanded state when not restrained in the collapsed state.The closure device expanded state may form a generally cylindrical shapedefining a lumen therethrough. The closure device may comprise a framestructure and a cover member coupled to the frame structure in at leastone location, wherein the frame structure is configured to retain aposition within the blood vessel in its expanded state, and wherein thecover member has a thickness and is configured to at least temporarilyresist the flow of blood across the thickness. The deployment member mayhave a proximal portion and a controllably movable distal portion, thedistal portion being coupled to the closure device, wherein the distalportion may be moved from a first configuration wherein the distalportion is substantially aligned with the proximal portion, to a secondconfiguration, wherein the distal portion is rotated relative to theproximal portion in a manner selected to prevent the closure device fromexiting the opening in the blood vessel. The controllably movable distalportion may be biased to rotate to the second configuration when notconstrained to remain in the first configuration. The apparatus mayfurther comprise a rotation actuating member that may be utilized toapply a tensile load to the movable distal portion to cause the distalportion to rotate.

DETAILED DESCRIPTION

Referring again to FIG. 1A, an introducer catheter (2) is shown with itsdistal tip (6) inserted across a hole formed in a blood vessel, such asan arteriotomy (28), which has been created in a blood vessel such asthe femoral artery (22) to provide transvascular access for a proceduresuch as a percutaneous heart valve installation. The hole or arteriotomy(28) may have a diameter as large as 18 French or larger. In FIG. 1A,the valve deployment related tooling has been removed, and hemostasisthrough the lumen (4) defined through the introducer (2) may becontrolled, for example, with valves integrated into the introducer orpositive flush from an associated flush assembly (8). The embodimentdepicted in FIG. 1A shows a closure device assembly being insertedthrough the introducer to facilitate execution of a controlledarteriotomy closure, the device assembly generally comprising acollapsed closure device (14), an elongate deployment member (10) havinga distal portion (12) configured to removably accommodate the collapseddevice (14), an insertion/retraction member (16) removably coupled withthe device (14), a deployment tension member (18) configured to causethe collapsed device (14) be expandable to a deployed or expanded shape,and an attachment tension member (20) configured to pull the deviceproximally toward the operator of the assembly. In one embodiment theclosure device (14) may be selected to span and close an arteriotomyhaving a diameter as large as 18 French or larger. The elongatedeployment member preferably comprises a flexible material construct,such as a polymer extrusion. The deployment and attachment tensionmembers preferably comprise relatively small diameter sutures, wires, ortensile load bearing lines made from polymers and/or metals, such aspolyethylene, polyethylene terephthalate, stainless steel, titanium,nitinol, and the like. An insertion/retraction member (16) preferably iscapable of not only withstanding tensile loads, but also relativelylow-level compressive loads, as in a scenario wherein such structure isutilized to push a device (14) distally. Suitable materials for aninsertion/retraction member (16) include the polymers and metalsmentioned above in reference to the tension members (18, 20; inconstruction, given the desirable compressive functionality in additionto tensile, the insertion/retraction member generally will be stiffer,and potentially larger in diameter, as compared with such tensionmembers (18, 20). The collapsed closure device (14) may comprise aplurality of flexible structural frame elements coupled together to forma collapsible and expandable member having an outer shape that issubstantially cylindrical in both collapsed form and expanded form, anddefining a lumen through the cylindrical expanded form, with generallyno lumen defined through the generally cylindrical collapsed form.Further description of suitable closure device (14) details is featuredbelow.

Referring to FIG. 1B, the delivery member (10) has been inserted fartherthrough the introducer (2), and the distal portion (12) of the deliverymember (10), with the collapsed device (14) confined therein, is beingpositioned past the distal tip of the introducer (6) and into the bloodvessel (22).

Referring to FIG. 1C, with insertion of the insertion/retraction member(16) relative to the delivery member (10), the collapsed device (14) maybe pushed out of the confining distal portion (12) of the deliverymember (10) and into the free bloodstream space of the vessel (22). Theattachment tension member (20) may then be tensioned to maintain thecollapsed device in a position adjacent to the distal tip (6) of theintroducer (2) as the delivery member (10) is retracted relative to theintroducer (2), as shown in FIG. 1C.

Referring to FIG. 1D, with tensioning of the deployment tension member(element 18 in FIGS. 1A-1C), the device may be allowed to expand to anexpanded shape (element 24 refers to the expanded form of the previouslycollapsed closure device, element 14) preferably substantially occupyingthe entire cross section of the blood vessel (22) and spanning wellbeyond the diameter of the arteriotomy (28) with space on either side toprevent exit of the closure device (24) through the arteriotomy (28).The deployment tension member (18) may comprise an elongate cable,suture, string, or the like configured to occupy very little crosssectional space, and to be able to withstand tensile loading sufficient,for example, to untie a knot configured to maintain the device in acollapsed configuration. One suitable tying or knot configurationcomprises what is known as a “highwayman's hitch” tied around thecollapsed device (element 14 in FIGS. 1A-1C); with such a configuration,a controlled tensile pull on the deployment tension member from anoperator at the proximal end of the instrument assembly causes thehighwayman's hitch to untie, allowing the device to expand. Expansionfrom a collapsed state to an expanded state may be accomplished using aself-expanding device structure configured to expand itself to a finalexpanded shape, or an expandable shape configured to be expanded from acollapsed state to an expanded shape with the assistance of a balloon orother expansion device which may be placed through the device. Inanother embodiment, an expansion device comprising an expandable balloonor other expandable member configured to controllably expand based atleast in part upon thermal energy, electric energy, shape memory, and/orhydrophilic expansion may be utilized to complete expansion of a deviceconfiguration which at least partially expands on its own, but which mayrequire assistance to expand fully. As shown in FIG. 1D, the expandedclosure device (24) remains coupled to the attachment tension member(20), and the introducer remains located adjacent to the expanded device(24), holding the arteriotomy (28) open and providing a conduit for theattachment tension member to be used to make small adjustments in thepositioning of the expanded device (24) relative to the blood vessel(22) structure.

Referring to FIG. 1E, with the expanded device (24) in a desirableposition, the introducer catheter (2) has been removed, allowing thearteriotomy (28) to close to a greater degree as it still surrounds theattachment tension member (20) which continues to be coupled to theexpanded device (24). The attachment tension member (20) may then bereleased or uncoupled from the deployed device (24) with a cutting tool(26), or controlled detachment configuration, such as a small mechanicallatch or fitting, or a controlled release link configuration described,for example, in U.S. Pat. No. 5,122,136, which is incorporated byreference herein in its entirety. Uncoupling of the attachment tensionmember (20) from the device (24) allows for the arteriotomy (28) tocompletely close, leaving behind an access closure supported at least inpart by the expanded device.

FIG. 1F depicts a cross sectional view of the configuration illustratedin FIG. 1E. Referring to FIG. 1F, the attachment tension member (20) isshown coupled to the expanded closure device (24) and leading out of thecollapsing/closing arteriotomy (28). Subsequent to decoupling of theattachment tension member (20) from the device (24), complete hemostasisof the arteriotomy may be accomplished based upon one or more of severalfactors: 1) the device may be configured to bias the arteriotomy closed;2) the vessel wall tissue defining the arteriotomy therethroughgenerally is self-biased to close (with a somewhat spring-like state oftissue mechanics in a vessel wall, the wall is generally biased to closewhen mechanically allowed to do so); 3) the device (24) may comprise astructure or materials which are specifically configured to prevent theflow of blood through the wall at the location of the arteriotomy. Manysuitable construction variations may be utilized for the closure device(14, 24); for example, the device embodiment depicted in FIG. 1F,comprises a frame comprised of frame elements or structural members (30)which are coupled to a thin, sheetlike connecting material (34)configured to be substantially impermeable to blood, and therefore ablocking element is pressed adjacent the arteriotomy (28) location tofacilitate hemostatic across the arteriotomy (28) until it has healedshut. The outer surface of the structural member (30)/connectingmaterial (34) assembly may be coupled to cover structure (32), and maybe relatively thick (in one embodiment having a substantially uniformthickness of about 0.015 inches) as compared with the connectingmaterial (34), which may be further selected for its ability tofacilitate hemostatic of the arteriotomy (28). Suitable materials forconnecting material (34) and cover structures (32) includepolytetrafluoroethylene (“PTFE”), expanded polytetrafluoroethylene(“ePTFE”), polyethylene terephthalate (“PET”), polyesther, polylacticacid (“PLA”), poly glycolic acid (“PGA”), poly-lactic-co-glycolic acid,fluorinated ethylene-propylene, silicone, polyethylene, polyurethane,copolymers of any of the above, other polymers, as well as porcine orequine submucosa. The structural members (30) may comprise metals, suchas nitinol, or polymers, such as resorbable polymers, as described belowin reference to the construction of the collapsed (14) or expanded (24)forms of suitable closure devices.

In one embodiment, a cover structure may be biased to maintain asubstantially cylindrical outer surface shape, and to assist inspreading loads from the structural members (30) substantially uniformlyto surrounding tissue via such substantially cylindrical outer surfaceshape. The closure device embodiment depicted in FIG. 1F, when in theexpanded configuration as shown, forms a substantially cylindrical outershape defining a lumen therethrough; the substantially cylindrical outershape interfaces with substantially all (i.e., approximately 360 degreesof the circumferential inner surface 238 of the vessel 22 which definesthe vessel lumen 236) of the interior surface (238) of the blood vessel(22) in the region of the arteriotomy (28), including in thisembodiment, the portions of this inner surface (238) which extend alongthe longitudinal axis of the vessel on either side of the arteriotomy(28) for a given distance each way. In other words, if an arteriotomy iscreated at a position approximately midway along a two-inch-long,generally cylindrical vessel portion of interest, in one embodiment, aportion of the expanded closure device may be configured to interfacewith substantially all of the two-inch-long, generally cylindrical,inner surface (238). In other embodiments, an expanded closure devicemay be configured to interface with less than substantially all 360degrees of this circumferential surface. For example, Referring to FIG.1K, an embodiment is depicted that is similar to that depicted in FIG.1F, with the exception that an expanded closure device (240) directlyinterfaces with approximately 90 degrees (244) of the circumferentialinner surface (238) of the vessel (22). FIG. 1L depicts an embodimentwherein an expanded closure device (242) directly interfaces withapproximately 135 degrees (246) of the circumferential inner surface(238) of the vessel (22). The embodiment depicted in FIG. 1G varies fromthat of FIG. 1F in that the cover structure (32) of FIG. 1F isconfigured to cover substantially the entire approximately cylindricalouter surface of the structural member (30)/connecting material (34)assembly, while the cover structure (32) of FIG. 1G is configured tocover the approximately ⅔ of the approximately cylindrical outer surfaceof the structural member (30)/connecting material (34) assembly closestto the arteriotomy location.

Many closure device (14) variations are suitable, with general preferredcharacteristics being that the device be deployable through thearteriotomy in a collapsed state, and expandable once in the targetedvessel to an expanded state which promotes closure of the hole orarteriotomy through which it was delivered. For example, in oneembodiment shown in orthogonal view in FIG. 1H, the closure device maycomprise a simple scaffold or frame constructed of bent and straightportions of elongate structural members (30) in a coiled, meshed,zig-zag, or other pattern coupled to a cover structure (32) positionedto promote hemostasis of the arteriotomy (28). Such structural members(30) may, for example, comprise highly flexible metallic alloys orpolymeric materials, such as bioresorbable polymers. Suitable metallicalloys include nickel titanium alloys, such as the superalloy known asnitinol; other suitable materials include stainless steel, cobaltchrome, titanium, nickel, gold, tantalum, and alloys thereof. Suitablepolymeric materials include those comprising poly lactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), silicone, polyethylene,polyurethane, polyesther, and copolymers thereof.

In another embodiment, such as that shown in FIGS. 1I and 1J, a suitableclosure device (14) may comprise merely a scaffold or frame comprisingbent and/or straight portions of elongate structural member (30)material in a configuration that tends to bias an arteriotomy (28)closed when in a deployed/expanded configuration by urging adjacentvessel (22) wall tissue portions (36, 38) toward each other by means ofsmall hooks, or high-friction or protein binding materials that areconfigured to attach or adhere to the inside of the vessel wall.

In another embodiment, a closure device (14) may comprise an expandablescaffold or frame such as an intraluminal stent or stentlike structure.The stent may be self-expanding or balloon-expandable and may be a stentconfigured for any blood vessel including coronary arteries andperipheral arteries (e.g., renal, Superficial Femoral, Carotid, and thelike), a urethral stent, a biliary stent, a tracheal stent, agastrointestinal stent, or an esophageal stent, for example. Morespecifically, the stent may be, for example, a stent availablecommercially as a Wallstent, Palmaz-Shatz, Wiktor, Strecker, Cordis, AVEMicro Stent, Igaki-Tamai, Millenium Stent (Sahajanand MedicalTechnologies), Steeplechaser stent (Johnson & Johnson), Cypher (Johnson& Johnson), Sonic (Johnson & Johnson), BX Velocity (Johnson & Johnson),Flexmaster (JOMED) JoStent (JOMED), S7 Driver (Medtronic), R-Stent(Orbus), Tecnic stent (Sorin Biomedica), BiodivYsio (BiocompatiblesCardiovascular), Trimaxx (Abbott), DuraFlex (Avantec Vascular), NIRstent (Boston Scientific), Express 2 stent (Boston Scientific), Libertestent (Boston Scientific), Achieve (Cook/Guidant), S-Stent (Guidant),Vision (Guidant), Multi-Link Tetra (Guidant), Multi-Link Penta(Guidant), Multi-Link Vision (Guidant), Gianturco-Roubin FLEX-STENT®,GRII™, SUPRA-G, or V FLEX coronary stents from Cook Inc. (Bloomington,Ind.). Some exemplary stents are also disclosed in U.S. Pat. Nos.5,292,331 to Boneau, 6,090,127 to Globerman, 5,133,732 to Wiktor,4,739,762 to Palmaz, and 5,421,955 to Lau, each of which is incorporatedby reference herein in its entirety. Suitable expandable stentlikestructures are also disclosed in percutaneous valve configurationdisclosures. For example, the configuration disclosed in U.S. Pat. No.7,445,631 to Sadra Medical, Inc., absent the valve leaflets, may besuitably used in the subject application; U.S. publication 2009/0210052to Forster et al discloses (for example, FIGS. 2A-2C) a tri-starcollapsible frame configuration which may be utilized absent the valveleaflets in the subject application; each of these references isincorporated by reference herein in its entirety.

Any of the above devices, scaffolds, frames, stents, or stentlikestructures may be combined with strips, sheets, or sheetlike portions ofconnecting material, such as PTFE or ePTFE, to form what may be referredto as a variant of a stent graft. A suitable stent graft is described,for example, in PCT Publication WO 1997-021403 to Prograft Medical, andis incorporated by reference herein in its entirety. Further, any of theaforementioned frames may be coupled to a cover structure (with orwithout connecting material as well) comprising a metal or polymermaterial positioned to assist in maintaining hemostasis of thearteriotomy, as depicted in FIGS. 1F-1H.

Referring to FIG. 2A-2I, another embodiment is depicted wherein aclosure device (40) has two end portions coupled by a highly bendablemidportion. Referring to FIG. 2A, a distal tip (6) of an introducercatheter (2) is positioned through an arteriotomy (28) formed in a bloodvessel (22). In one embodiment, the arteriotomy may be as large as 18French or larger in diameter. An access closure device deploymentassembly is shown being advanced toward the introducer (2) in FIG. 2B,the assembly comprising an expandable device (40) removably coupled to adeployment tension member (19) and an attachment tension member (21),each of which are movably coupled through a device insertion/retractionmember (16) to a proximal location where they may be manipulated orcontrolled by an operator.

Referring to FIG. 2C, the insertion/retraction member (16) is withdrawnrelative to a delivery member (10), causing the collapsed device (40) tobecome disposed within the distal portion (12) of the delivery member(10). Such a configuration may be inserted into the introducer catheter(2), as shown in FIG. 2D, to dispose the collapsed device (40) past thedistal tip (6) of the introducer (2). Referring to FIG. 2E, theintroducer (2) may be withdrawn to urge the collapsed device (40) into aposition wherein it is approximately centered adjacent the arteriotomy(28) to provide a temporarily hemostasis through the arteriotomy (28).Referring to FIG. 2F, having placed the non-expanded device (40) in adesirable position as in FIG. 2E, the deployment tension member (19) maybe proximally tensioned to allow the device to expand, such as by usinga highwayman's hitch as described above, and the attachment tensionmember (21) may be subsequently uncoupled from the expanded device (42)to allow for the arteriotomy (28) to close and for the deliveryinstrumentation to be removed. As shown in FIG. 2F, for example, thedeployed device (42) spans across the longitudinal length of thearteriotomy (28) with extra length on both sides to provide stabilityand leak prevention. Referring to FIGS. 2G-2I, three views of a suitablestructural member frame for the deployment paradigm illustrated in FIGS.2A-2F are depicted to show that two substantially cylindrical endportions (44, 46) are coupled by a highly flexible mid portion (48) inthis embodiment, the midportion (48) preferably being positioneddirectly adjacent the arteriotomy location to provide support for theclosure (i.e., by urging a related cover member directly against thearteriotomy location); such preferred position/orientation of theflexible mid portion (48) may be accomplished, at least in part, byinterfacing a tensile member (not shown) directly with the midportion(48), for example by tying with a knot to one of the small aperturesshown in the midportion (48) embodiments of FIGS. 2G-2I. Tension on sucha tensile member is likely to assist with the orientation/positionselection described herein, either before or after allowing the deviceto reach its expanded state. Such structural members may comprisematerials similar to the structural members (30) described in referenceto FIGS. 1A-1J, and may be coupled to sheetlike members and/or covermembers for form a substantially cylindrical expanded device surfaceshape (as in the embodiment shown in FIG. 2F wherein a cover member 30extends around each of, and between (i.e., across the midportion 48span), the two zig zag cylindrical frame sub-portions 44, 46, to spanthe arteriotomy 28 and play a key role in effecting the closurethereof), which also may be similar to those (34, 32) described above inreference to FIGS. 1A-1J. In other words, the embodiment shown in FIGS.2A-2F, while delivered in a two-lobed collapsed form, may be expanded toform a substantially cylindrical shape due to a sheetlike member coupledacross the frame, and/or a cover member extended across the outersurfaces of the frame.

Referring to FIGS. 3A-3D, a roll-up type expandable device (5)configuration is depicted to illustrate that suitable prostheses neednot be conventionally radially expandable—they may be expanded byallowing, or mechanically facilitating (i.e., with an assisting devicesuch as a balloon or unrolling torque tool), the unrolling or unfurlingof a device that has been rolled into a smaller radial configuration, asillustrated in FIG. 3C.

Referring to FIG. 4, one embodiment of a handle is depicted fordeploying and actuating configurations such as those described inreference to FIGS. 1A-1J and 2A-I. As shown in FIG. 4, an actuatorhandle body (56) is movably coupled to a delivery member (16)insertion/retraction actuator slide button (54) and a deployment tensionmember (18, 19) tension actuation pull feature (52). Such aconfiguration allows for an operator to hold the handle body (56) in onehand and easily control insertion and retraction of theinsertion/retraction member (16) with a thumb or finger of the samehand, while also allowing for the operator to use fingers of the otherhand to pull the deployment tension member (18, 19) tension actuationpull feature (52) and allow a related device to expand or be expanded.

Referring to FIG. 5, a method is illustrated wherein an arteriotomy iscreated, an introducer inserted, and a diagnostic or interventional toolinserted through the introducer (58) to conduct a cardiovascularprocedure (60) such as a percutaneous valve replacement. After thediagnostic and/or interventional tool or tools have been retracted backthrough the introducer (62), it may be desirable to close thearteriotomy. A distal tip or portion of the introducer may be retractedto a position close to the arteriotomy (64) but still within the vessel,and a closure assembly comprising an expandable device configured tofacilitate hemostatic of the arteriotomy may be inserted through theintroducer toward the arteriotomy (66). The closure assembly distalportion may be inserted past the arteriotomy and into the vascular lumen(68), after which the device may be positioned and/or repositioned to adesired location relative to the arteriotomy and surrounding anatomy(70). The device may then be allowed to expand, or may be expanded, tocause hemostasis at the arteriotomy (72), and the closure assembly andintroducer may be withdrawn away from and detached from the expandeddevice, leaving a closed arteriotomy (74).

Referring to FIGS. 6A-6X, various aspects of another embodiment of aclosure assembly are depicted, wherein a collapsed closure device may becontrollably repositioned and/or reoriented during a deployment processin a manner that geometrically prevents such device from escaping thearteriotomy as other delivery tools subsequently are removed, and alsolimits or reduces blood or other fluids from escaping the arteriotomyonce the device has been expanded into a final configuration, therebyeffectively closing the arteriotomy. Referring to FIG. 6A, a deliveryassembly is depicted comprising an outer introducer sheath (2), adelivery sheath (76) placed through the working lumen of the introducersheath (2), and a arteriotomy closure device deployment assemblythreaded through the working lumen of the delivery sheath (76), theassembly being depicted in FIG. 6B without the sheaths and featuring acollapsed closure device (86) coupled to both an elongate deploymentmember (90) and a foot member (92), the foot member being threadedthrough a working lumen defined by a portion of the deployment member(90). The closure device (86) may comprise an expandable frame,scaffold, or prosthesis with or without associated sheetlike membersand/or cover members, and may be similar to those described above inreference to FIGS. 1A-3D, or below in reference to FIGS. 6K-6V. Adeployment tension member (82), such as a suture or wire, is threadedthrough another working lumen defined by a portion of the deploymentmember (90) and looped around the collapsed closure device (86) as wellas a portion of the foot member (92) to maintain the collapsedconfiguration of the closure device until the deployment tension memberis tensioned, causing a releasable knot (83), such as a highwayman'shitch, to release and allow the collapsed closure device to expand or beexpanded. An attachment tension member (84), such as a suture or wirethat may be resorbable, akin to the attachment tension members (20, 21)described above, is threaded through a lumen or channel defined by thefoot member (92) and tied to the closure device (84).

Referring to FIGS. 6C-6E, one configuration for controllablyrepositioning and/or reorienting a collapsed closure device (86) duringdeployment is configured. As shown in FIG. 6C, application of a load(100) to the elongate deployment member (90) initially will result in acompressive load at the interface (94) between the elongate deploymentmember (90) and the collapsed closure device (86). This compressiveloading may result in translational repositioning of the closure device(86) initially until there is no more slack in the attachment tensionmember (84), after which a moment will be effectively applied to theclosure device (86), causing it to rotate (98), or rotationallyreorient, relative to the elongate deployment member, as depicted inFIGS. 6D and 6E. FIG. 6E, in particular, diagrammatically illustratesthat a compressive interfacial load (94) applied along with a tensileload (96) through the attachment tension member (84) attached at adifferent location from the interfacial load application results in arotation actuation. In one embodiment, rotational actuation may beaccomplished by both actively tensioning the attachment tension member(84) and actively pushing the elongate delivery member (90). In otherembodiments, only one of such members (84, 90) may be actively loaded,with the other kept relatively stationary. For example, referring toFIG. 6D, the attachment tension member (84) is shown grounded oranchored at a proximal location, so that rotation of the collapsedclosure device (86) may be induced merely with compression or pushingupon the elongate deployment member (90) after slack in the attachmenttension member (84) has been eliminated. Such rotation causes bending orhinging of a distal portion of the foot member at a predetermined hingeor bending axis (102), and the amount of rotational reorientation may bephysically limited by the positions of distal portions of the elongatedelivery member (90).

Referring to FIGS. 6F-6H, components of the above described deliveryassembly are shown disassembled to some degree. FIG. 6F depicts a footmember (92) coupled to a collapsed closure device (86) with a deploymenttension member (82) and attachment tension member (84). FIG. 6Gillustrates an elongate deployment member comprising a first guide tube(104) coupled to a second guide tube (106) with a deployment memberouter layer (108), as shown in the orthogonal view of FIG. 6H. Bothguide tubes (104, 106) define working lumens therethrough (150, 152,respectively). In the assembly of FIG. 6C, for example, a deploymenttension member (82) may be passed through the first guide tube lumen(150), and a foot member (92), which itself defines a lumen throughwhich an attachment tension member (84) may be passed, may be placedthrough the second guide tube lumen (152).

Referring to FIGS. 6I and 6J, orthogonal side views of a foot member(92) embodiment are depicted. In the depicted embodiment, the proximalportion (142) of the foot member may comprise a flexible tube comprisinga polymer such as fluorinated ethylene-propylene, and the distal portion(110) may comprise a mechanically flattened continuation of such tubingconfigured with holes (112) to accommodate knots and fastening of adeployment tension member (element 82 in FIG. 6C, for example) and/orattachment tension member (element 84 in FIG. 6C, for example). A creaseis provided to create a preferred bending or hinging axis (102) betweenthe proximal (142) and distal (110) portions of the foot member. Inanother embodiment, the proximal portion (142) of the foot member maycomprise a reinforcing material or member, such as a piece of metalhypotube, to increase the structural modulus of such portion andfacilitate precise positioning and loading of such portion to maneuverthe delivery assembly or portions thereof.

Referring to FIGS. 6K-6M, as described above, the closure device may bean expandable or self expanding device that is configured to betransformable from a collapsed state to an expanded state whenunrestrained, in the case of a self expanding configuration, orunrestrained and actively expanded (for example, with an expansionballoon), in the case of an actively expandable configuration. Expansionof one embodiment is depicted in the transformation between FIG. 6K andFIG. 6L, wherein the collapsed closure device (86) is freed from theconstraints of one or more restraining members, such as a lumen orlumens of one or more sheaths, or one or more deployment attachmentmembers which may be looped around the collapsed configuration. FIG. 6Millustrates an orthogonal view of the expanded configuration of FIG. 6L.The expanded configuration of the depicted embodiment, illustrated inFIGS. 6L and 6M, comprises an expanded form of an expandable closuredevice (114) featuring a cylindrical pattern of nitinol frame elementsor structural members (30), coupled to a cover structure (32), similarto those described above in reference to FIGS. 1A-1J and 2A-2I. Asheetlike member may also be coupled to the frame elements to assistwith arteriotomy closure, as described above. As described above,preferably the cover (32) is sized to not only contain substantially theentire structure when in a collapsed configuration, but also to providean additional layer of arteriotomy closure and leak prevention when thedevice has been expanded and the cover (32) has been oriented directlyadjacent the location of the arteriotomy. Also as described above, thecover (32) may comprise a bioresorbable material, and in otherembodiments, elements of the closure device (14, 24) structure maycomprise a polymeric material which also may be bioresorbable. The cover(32) may be coupled to the closure device (114) using a clip, wire, orsuture which may be looped around one of the frame elements (30) andthrough the material comprising the cover (32). Geometric features maybe created in the closure device to assist with such coupling, and maybe configured to allow for coupling of the cover and closure devicewithout a clip, wire, or suture.

Referring to FIGS. 6N-6O, three different views of a closure deviceframe or scaffold (116) configuration comprising two crowns coupledtogether, using a weld or adhesive junction, for example, areillustrated. A clip, wire, or suture around one of the crown junctionsmay be utilized to couple a cover to such device.

Referring to FIGS. 6Q and 6R, two different views of a closure deviceframe or scaffold embodiment (118) are shown wherein a small loopfeature (119) has been formed to assist with the coupling of suchscaffold and a cover. FIG. 6S depicts a similar embodiment (120) havinga larger loop feature (121). FIG. 6T depicts an embodiment (124) whereina loop feature (125) is formed with an end to end structural memberjunction that may comprise welds or adhesive junctions; FIG. 6U depictsa similar embodiment (126) with a larger loop feature (127). FIG. 6Vdepicts an embodiment (128) having several features of interest,including an end to end crimp tube junction (131), a small bend feature(130) which may be positioned to contain or assist with coupling anassociated cover member, and two pinch coil features (129) configured toretain a portion of a cover member with a pinch friction/load fit,somewhat akin to that provided to a piece of paper with a paper clip. Inother embodiments, pinch coil features (129) may be created at variouslocations about the closure device frame or scaffold structure, inaddition to the end apex locations as shown in the variation of FIG. 6V.

FIG. 6W illustrates a side view of a delivery sheath (76), which maycomprise a generally cylindrical polymeric tube with sequentiallystepped down outer diameter shaping (to provide greater flexural modulusperformance and shaping distally) and an atraumatic tip (79) similar tothat shown in FIG. 6A (element 78 of FIG. 6A) comprising a partiallyhemispheric or capsular arcuate geometry with notches (80) to allow forpassage of closely fit objects (i.e., by bending forward/distally one ormore of the plurality of atraumatic tip flaps formed by the notches 80and capsular shape of the atraumatic tip 79) through a working lumenwhich preferably is formed and defined through the sheath (76). Asdescribed above, the introducer illustrated in FIG. 6A, for example, hassimilar atraumatic tip features, including a notched (80) partiallyhemispheric or capsular arcuate geometry (element 78 of FIG. 6A)configured to accommodate the passage of relatively closely fit objects(i.e., by bending forward/distally one or more of the plurality ofatraumatic tip flaps formed by the notches 80 and capsular shape of theatraumatic tip, element 78 of FIG. 6A).

FIG. 6X illustrates aspects of the proximal portions of a deliveryassembly which may be utilized with a distal deployment configurationsuch as that illustrated in FIG. 6A. Referring to FIG. 6X, the outermostlayer of the distal aspects of the depicted configuration comprises thedelivery sheath (76), which terminates proximally with a delivery sheathhub (77) configured to be manipulated by an operator. Within the lumendefined by the delivery sheath is a delivery assembly comprising anelongate deployment member (90) movably coupled to a foot memberproximal portion (142). The elongate deployment member (90) terminatesproximally with an elongate deployment member hub (91) configured to bemanually manipulated by an operator. This hub (91) features a releasabletermination screw to fix one end or one portion of a deployment tensionmember (82), the other portion or end of which may be coupled to a pulltab (132) configured for tension manipulation by an operator—to, forexample, untie a highwayman's hitch knot configured to releasablycontain a closure device in a collapsed configuration. The elongatedeployment member hub (91) also features a screw (144) adjustablecompression spring (146). The proximal portion of the foot member (142)terminates proximally in a foot hub (140) configured to be manuallymanipulated by an operator. A set screw (138) may be utilized to fastenthe hub (140) to the. The attachment tension member (84) is proximallyrouted through the proximal portion of the foot member (142) to areleasable fixation screw (136) proximal portion of the foot member(142), which, as described above, may be reinforced by, or may comprise,a relatively stuff material or construct, such as a metal hypotube. Inoperation, when an operator wants to induce rotation and/or translationof a collapsed closure device, as described, for example, in referenceto FIGS. 6C-6E, he may longitudinally reposition the elongate deploymentmember hub (91), foot member hub (140), and attachment tension member(84) tensioning to create such rotation and/or translation of the distalfoot portion and collapsed closure device. A compression spring seat(148) coupled to the proximal portion of the foot member (142) appliesloads to the proximal portion of the foot member (142) as the footmember hub (140) is pushed toward the elongate deployment member hub(91). A shoulder bolt (134) maintains the orientation of the foot memberrotationally to allow the operator to understand the direction offlexion of the foot member upon desired rotation and/or translation. Thecompression spring adjustment screw may be tightened to pre-bias thedistal foot portion to flex when released from constraining members,such as one or more sheaths which may temporarily surround andmechanically constrain the distal foot portion (i.e., thereby urging thedistal foot straight as opposed to flexed). Alternatively, the springmay be left relatively unloaded to allow for release from constrainingmembers without pre-biased flexion actuation, followed by controlledflexion actuation using the various hubs and attachment tension element.Aspects of embodiments of such operation are described in reference toFIGS. 7A-7F, and 8A-8B.

Referring to FIG. 7A, an assembly has been inserted through anarteriotomy (28) and advanced forward to place a collapsed closuredevice (86), such as those described above in reference to FIG. 1A-1J,2A-2I, 3A-3D, or 6L-6V, within a blood vessel (22) and surrounded by oneor more sheaths (76, 2). In some embodiments, the arteriotomy (28) mayhave a diameter as large as 18 French or greater. Referring to FIG. 7B,to begin deployment of the closure device (86), the introducer sheath(2) may be withdrawn proximally using an introducer manipulation hub(3), and/or the elongate deployment member (90) and foot member (142)may be advanced distally, to further expose the collapsed closure device(86). Referring to FIG. 7C, the delivery sheath (76) and collapsedclosure device (86) may be moved relative to each other to furtherexpose the collapsed closure device (86). Referring to FIG. 7D, theexposed collapsed closure device (86) may be controllably translatedand/or rotated to cause rotational reorientation to a toggled position.Referring to FIG. 7E, the closure device (86) is intentionallydimensioned to not be easily passable through the arteriotomy when inthe toggled position. In one embodiment, the closure device (86) mayhave a proximal portion, centerpoint, and distal portion along an axisparallel to a longitudinal axis of the closure device when collapsed orexpanded. Preferably the total length of the device along this axis isgreater than the largest dimension of the arteriotomy, and preferablythe distal portion and proximal portion are long enough to preventadditional rotation of the device relative to the vessel. In oneembodiment, the attachment tension member (84) may be tensioned to placethe collapsed closure device (86) against the arteriotomy with thecentral point (154), adjacent to which the attachment tension memberpreferably is terminated upon the device, aligned with the center of thearteriotomy (28), and the proximal (156) and distal (158) portions ofthe device extending away from the arteriotomy (28). In other words,upon controlled repositioning and/or reorientation of the collapsedclosure device to the toggled or rotated position, further withdrawal ofthe closure device out of the arteriotomy is prevented by virtue of thegeometry of the arteriotomy and closure device, the device in thedepicted embodiment (86 collapsed; 88 expanded) spanning across thediameter of the previous arteriotomy location with extra length to spareon either side of this previous arteriotomy location. Referring to FIG.7F, the deployment tension member (not shown) has been tensioned toallow the closure device to take its expanded shape (88), preferablyurging the associated cover against the inside of the arteriotomy, whichshrinks to a closed configuration (27) when all of the hardware has beenwithdrawn with the exception of the attachment tension member (84),which is configured to remain attached to the expanded device (88), andis preferably configured to subsequently biologically erode after beingclipped most proximally and allowed to stay inside of the body aftertranscutaneous wound closure.

Referring to FIG. 8A, a deployment process is outlined, whereinsubsequent to transcutaneous access and arteriotomy creation (160), anintroducer and associated hardware may be inserted through thearteriotomy and advanced through a portion of the artery (162). Adeployment assembly may be advanced (164) with the introducer, orsubsequently advanced, and may be exposed by moving the introducerlongitudinally relative to the deployment assembly. In one embodimentwherein the foot member is pre-biased to reorient by a proximal loadingconfiguration such as a compressed compression spring, when the distalportion of the foot member is cleared of mechanical confinement by adelivery sheath or introducer sheath, it flexes at the foot hinge orbend axis to reorient the collapsed closure device. In preparation forsuch reorientation, the introducer may be moved proximally relative tothe closure device (166). In the depicted embodiment wherein the footmember is pre-biased to flex when not constrained, the last anti-flexionconstraint, the delivery sheath, is withdrawn relative to the footmember, closure device, and elongate delivery member, and the closuredevice and distal portion of the foot become reoriented (168).Subsequently, the introducer, delivery sheath, and foot member/elongatedelivery member assembly may be withdrawn to allow the closure device tobe urged against the arteriotomy with tension in the attachment tensilemember (170). Subsequently, the deployment tension member may becontrollably tensioned to allow the closure device to expand in positionagainst the arteriotomy, preferably with a cover portion of the closuredevice positioned immediately adjacent the arteriotomy location (172).The deployment and access tools may be withdrawn, leaving behind onlythe expanded closure device and the attachment tension member, or“tether line” (176), which may subsequently be shortened prior totranscutaneous access closure (176).

Referring to FIG. 8B, another embodiment is depicted, differing fromthat of FIG. 8A in that the foot member is not pre-biased to flex uponrelease from constraining members such as an introducer sheath ordelivery sheath. In the embodiment of FIG. 8B, the collapsed closuredevice may be exposed to the bloodstream while the foot remains in anun-flexed configuration, and when the operator desires, may becontrollably rotated and/or translated into the rotated configurationwith a flexion inducing load applied deliberately (169).

Referring to FIGS. 9A-9E, another closure device deployment embodimentis depicted, wherein an elongate bending spring member is built into thefoot member to pre-bias the foot to flex when not constrained by aconstraining structure such as a delivery or introducer sheath.Referring to FIG. 9A, an assembly somewhat similar to that depicted inFIG. 6A is depicted, with the exception that the foot member (93)comprises an elongate bending spring member (178) extending through thedistal portion of the foot member, and also through some of the distalend of the proximal portion of the foot member. Preferably the elongatebending spring member (178) comprises a pre-bent metallic or polymericmember and is configured to assume a foot flexion position, as depictedin FIG. 9B, for example, when not otherwise constrained by a sheath orother constraining member to assume a straight position, as shown inFIG. 9A. In one embodiment the elongate spring member comprises nitinolsuperalloy wire in a “V” shape as in FIG. 9D, and is coupled to proximaland distal foot member structures using interference fitting and adiscrete adhesive coupling at the distal tip of the “V” shape. In otherembodiments, the elongate spring member may comprise other biocompatiblemetals, such as stainless steel, cobalt chrome, titanium, nickel, gold,tantalum and/or alloys thereof, as well as biocompatible polymericmaterials such as polytetrafluoroethylene, expandedpolytetrafluoroethylene, polyethylene terephthalate, polyesther,polylactic acid, poly glycolic acid, poly-lactic-co-glycolic acid,fluorinated ethylene-propylene, silicone, polyethylene, polyurethane,and/or copolymers of any of the above. Further details of an elongatespring foot member are depicted in FIGS. 9C-9E. Referring to FIG. 9C,the elongate bending spring member (178) extends nearly the entirelength of the distal portion (184) of the foot member (93), and arelative small length of the distal end of the proximal portion (182) ofthe foot member (93). When allowed to rotate (i.e., without a sheath orother constraint holding it straight), as in FIG. 9E, the foot memberdistal portion (184) is configured to rotate to a preselected angle(186) in accordance with the pre-shaped configuration of the elongatespring member, about an axis of rotation, or bending or hinge point,(180) that divides the proximal portion (182) from the distal portion(184). Referring to FIG. 9D, an orthogonal view illustrates theplacement of a collapsed closure device (86) relative to the distalportion (184) of the foot member, such distal portion (184) being in anunfolded configuration in FIG. 9D, to accommodate interfacing andcoupling with a collapsed closure device (86). Four holes in the distalportion (184) of the foot are configured to assist with releasablefastening of a deployment tension member (element 82 in FIG. 9A) using areleasable knot, such as a highwayman's hitch. The distal portion (184)of the foot member may be created by crushing flat a substantiallycylindrical piece of tubing comprising the proximal portion (182) of thefoot member, and creating an “H”-shaped slice in such flattened portionto create the wings (232, 234) configuration depicted in FIG. 9D. Eachof the wings (232, 234) is configured to be wrapped around the exteriorof a collapsed closure device (86) to form a stable saddle-likeinterface. Two additional holes (204, 206) are formed through the footmember (93), one (204) to accommodate a deployment tension member(element 82 in FIG. 9A), and the other (206) to accommodate anattachment tension member (element 84 in FIG. 9A). Some sampledimensions for one particular embodiment include a collapsed closuredevice length dimension (188) of about 0.5″, a bending axis to proximalend of collapsed closure device dimension (190) of about 0.125″, adistal tip of foot member to distal end of collapsed closure devicedimension (192) of about 0.25″, a distal end of collapsed closure deviceto distal wing edge dimension (194) of about 1/16″, a distal end of footmember to distal wing edge dimension (196) of about 5/16″, a deploymentmember hole to proximal wing edge dimension (198) of about 1/16″, and awing length dimension (200) of about 0.25″.

Referring to FIG. 10, a process for utilizing an arteriotomy closuresystem such as that described in reference to FIGS. 9A-9E is depicted,with steps similar to those described in reference to FIG. 8A, with theexception of inserting a deployment assembly wherein the associated footmember comprises a pre-formed nitinol (“NiTi” or nickel titanium alloy)member biased to flex the distal foot portion at the rotational (orhinge or bending) axis when freed of confinement by a confiningstructure such as a delivery or introducer sheath (208).

Referring to FIG. 11, a particular embodiment of a deployment sheath(76) is depicted, wherein a blood channel (210) is formed within theexterior surface of the sheath (76) to allow pressurized blood, whenpresent at the distal tip of the sheath (76), to flow from the distalend of the sheath, proximally through the channel (with an introducersheath in place over the deployment sheath, the channel would beconfined at the outer surface by the inside surface of the introducerlumen, but would remain free to flow through the channel proximally), toa lumen inlet (212), the associated lumen (214) being fluidly connectedwith a simple indicator fitting (216) configured to effectively ooze orsquirt blood when appropriate blood pressure is present at the distalend of the channel (210). Such a configuration may be utilized in therelatively high-pressure (relative to venous) arterial system wherearteriotomies are created, to provide an indication to an operator thatthe distal portion of the subject sheath (79) is exposed to arterialflow. In one embodiment, such an indication may be utilized to positionthe distal portion of such sheath (79) just at the transition out of thearteriotomy and into non-pressurized space, when conducting a closuredevice deployment, as described above.

Referring to FIGS. 12A-12D, various aspects of a manual interface orcontrol handle assembly for operating a closure device deploymentsystem, such as those described in reference to FIGS. 6A-6X and 9A-9E,are illustrated. Referring to FIG. 12A, in one embodiment the controlhandle assembly (220) comprising a manipulable handle housing (218) andtwo manually movable elements (222, 224) configured to assist withvarious aspects of the deployment, is coupled to an elongate deploymentmember (90). Referring to the partial cutaway view of FIG. 12B, a footmember (93) extends distally through the elongate deployment member (90)and proximally is coupled to the first manually movable element (222),which is slidably coupled to the handle housing (218) to facilitateconvenient thumb or finger insertion/retraction of the foot member (93)relative to the elongate deployment member (90). Extending proximallyfrom the foot member (93), an attachment tension member (84) is coupledto a second manually movable element (224) by way of a spring-loadedmechanical fitting (226) configured to provide the operator with atactile bump in tensile pull (using, for example, a small enlargement inthe tension member that passes a fitting within the spring-loadedmechanical fitting) when he is about to release the attachment tensionmember from the housing, such that it may be left in situ. In operation,when the second movable element (224) is pulled proximally by a smallamount (228) as in FIG. 12C, the movable element (224) detaches from thehousing. Additional proximal pulling (230) takes the attachment tensionmember (84) past the detent, bump, or pull limit tactile feedbackmechanism, to provide the operator with an understanding that pullingpast such point permanently releases the attachment tension member (84)from the housing (84) and the control handle assembly (220) in general.

Various exemplary embodiments of the invention are described herein.Reference is made to these examples in a non-limiting sense. They areprovided to illustrate more broadly applicable aspects of the invention.Various changes may be made to the invention described and equivalentsmay be substituted without departing from the true spirit and scope ofthe invention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention. Further, as will be appreciated by those with skill in theart that each of the individual variations described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinventions. All such modifications are intended to be within the scopeof claims associated with this disclosure.

Any of the devices described for carrying out the subject interventionsmay be provided in packaged combination for use in executing suchinterventions. These supply “kits” further may include instructions foruse and be packaged in sterile trays or containers as commonly employedfor such purposes.

The invention includes methods that may be performed using the subjectdevices. The methods may comprise the act of providing such a suitabledevice. Such provision may be performed by the end user. In other words,the “providing” act merely requires the end user obtain, access,approach, position, set-up, activate, power-up or otherwise act toprovide the requisite device in the subject method. Methods recitedherein may be carried out in any order of the recited events which islogically possible, as well as in the recited order of events.

Exemplary aspects of the invention, together with details regardingmaterial selection and manufacture have been set forth above. As forother details of the present invention, these may be appreciated inconnection with the above-referenced patents and publications as well asgenerally know or appreciated by those with skill in the art. Forexample, one with skill in the art will appreciate that one or morelubricious coatings (e.g., hydrophilic polymers such aspolyvinylpyrrolidone-based compositions, fluoropolymers such astetrafluoroethylene, hydrophilic gel or silicones) may be used inconnection with various portions of the devices, such as relativelylarge interfacial surfaces of movably coupled parts, if desired, forexample, to facilitate low friction manipulation or advancement of suchobjects relative to other portions of the instrumentation or nearbytissue structures. The same may hold true with respect to method-basedaspects of the invention in terms of additional acts as commonly orlogically employed.

In addition, though the invention has been described in reference toseveral examples optionally incorporating various features, theinvention is not to be limited to that which is described or indicatedas contemplated with respect to each variation of the invention. Variouschanges may be made to the invention described and equivalents (whetherrecited herein or not included for the sake of some brevity) may besubstituted without departing from the true spirit and scope of theinvention. In addition, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention.

Also, it is contemplated that any optional feature of the inventivevariations described may be set forth and claimed independently, or incombination with any one or more of the features described herein.Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin claims associated hereto, the singular forms “a,” “an,” “said,” and“the” include plural referents unless the specifically stated otherwise.In other words, use of the articles allow for “at least one” of thesubject item in the description above as well as claims associated withthis disclosure. It is further noted that such claims may be drafted toexclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claimelements, or use of a “negative” limitation.

Without the use of such exclusive terminology, the term “comprising” inclaims associated with this disclosure shall allow for the inclusion ofany additional element—irrespective of whether a given number ofelements are enumerated in such claims, or the addition of a featurecould be regarded as transforming the nature of an element set forth insuch claims. Except as specifically defined herein, all technical andscientific terms used herein are to be given as broad a commonlyunderstood meaning as possible while maintaining claim validity.

The breadth of the present invention is not to be limited to theexamples provided and/or the subject specification, but rather only bythe scope of claim language associated with this disclosure.

1. An apparatus for closing an opening in a blood vessel, comprising: aclosure device removably coupled to a delivery member, the closuredevice configured such that upon passage through the opening, theclosure device is: a. controllably expandable from a collapsed state toan expanded state, wherein the closure device restricts fluids fromexiting the opening; and b. controllably decouplable from the deliverymember.
 2. The apparatus of claim 1, wherein the closure device is aself expanding structure configured to expand itself from the collapsedstate to the expanded state when not restrained in the collapsed state.3. The apparatus of claim 2, wherein the closure device expanded stateforms a generally cylindrical shape defining a lumen therethrough. 4.The apparatus of claim 1, wherein the closure device comprises a framestructure and a cover member coupled to the frame structure in at leastone location, wherein the frame structure is configured to retain aposition within the blood vessel in its expanded state, and wherein thecover member has a thickness and is configured to at least temporarilyresist the flow of blood across the thickness.
 5. The apparatus of claim1, wherein the deployment member has a proximal portion and acontrollably movable distal portion, the distal portion being coupled tothe closure device, wherein the distal portion may be moved from a firstconfiguration wherein the distal portion is substantially aligned withthe proximal portion, to a second configuration, wherein the distalportion is rotated relative to the proximal portion in a manner selectedto prevent the closure device from exiting the opening in the bloodvessel.
 6. The apparatus of claim 5, wherein the controllably movabledistal portion is biased to rotate to the second configuration when notconstrained to remain in the first configuration.
 7. The apparatus ofclaim 5, further comprising a rotation actuating member that may beutilized to apply a tensile load to the movable distal portion to causethe distal portion to rotate.
 8. An apparatus for closing an opening ina blood vessel, the blood vessel having an inner surface that defines alumen having a longitudinal axis, comprising: an expandable closuredevice controllably expandable from a collapsed state to an expandedstate, and configured such that upon passage through the opening andexpansion to the expanded state, the closure device contacts at least 90degrees of an inner surface of the vessel adjacent the opening relativeto the longitudinal axis, and restricts fluids from exiting the opening.9. The apparatus of claim 8, wherein the closure device is a selfexpanding structure configured to expand itself from the collapsed stateto the expanded state when not restrained in the collapsed state. 10.The apparatus of claim 9, wherein the closure device expanded stateforms a generally cylindrical shape defining a lumen therethrough. 11.The apparatus of claim 8, wherein the closure device comprises a framestructure and a cover member coupled to the frame structure in at leastone location, wherein the frame structure is configured to retain aposition within the blood vessel in its expanded state, and wherein thecover member has a thickness and is configured to at least temporarilyresist the flow of blood across the thickness.
 12. The apparatus ofclaim 8, wherein the deployment member has a proximal portion and acontrollably movable distal portion, the distal portion being coupled tothe closure device, wherein the distal portion may be moved from a firstconfiguration wherein the distal portion is substantially aligned withthe proximal portion, to a second configuration, wherein the distalportion is rotated relative to the proximal portion in a manner selectedto prevent the closure device from exiting the opening in the bloodvessel.
 13. The apparatus of claim 12, wherein the controllably movabledistal portion is biased to rotate to the second configuration when notconstrained to remain in the first configuration.
 14. The apparatus ofclaim 12, further comprising a rotation actuating member that may beutilized to apply a tensile load to the movable distal portion to causethe distal portion to rotate.
 15. An apparatus for closing an opening ina blood vessel, comprising: a closure device that is controllablyexpandable from a collapsed state to an expanded state; wherein in thecollapsed state, the closure device is insertable through the opening inthe blood vessel, and wherein in the expanded state, the closure deviceis coupled to an inner surface of the blood vessel and configured torestrict fluids from exiting the opening.
 16. The apparatus of claim 15,wherein the closure device is a self expanding structure configured toexpand itself from the collapsed state to the expanded state when notrestrained in the collapsed state.
 17. The apparatus of claim 16,wherein the closure device expanded state forms a generally cylindricalshape defining a lumen therethrough.
 18. The apparatus of claim 15,wherein the closure device comprises a frame structure and a covermember coupled to the frame structure in at least one location, whereinthe frame structure is configured to retain a position within the bloodvessel in its expanded state, and wherein the cover member has athickness and is configured to at least temporarily resist the flow ofblood across the thickness.
 19. The apparatus of claim 15, wherein thedeployment member has a proximal portion and a controllably movabledistal portion, the distal portion being coupled to the closure device,wherein the distal portion may be moved from a first configurationwherein the distal portion is substantially aligned with the proximalportion, to a second configuration, wherein the distal portion isrotated relative to the proximal portion in a manner selected to preventthe closure device from exiting the opening in the blood vessel.
 20. Theapparatus of claim 19, wherein the controllably movable distal portionis biased to rotate to the second configuration when not constrained toremain in the first configuration.
 21. The apparatus of claim 19,further comprising a rotation actuating member that may be utilized toapply a tensile load to the movable distal portion to cause the distalportion to rotate.